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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item#: 47249236013; greater trochanter femoral nail; lot#: 63948458 (b)(4).Foreign report source: (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00033, 0001822565-2020-00133, 0001822565-2020-00134, 0001822565-2020-00135, 0001822565-2020-00136, 0001822565-2020-00138, 0001822565-2020-00140, 0001822565-2020-00141, 0001822565-2020-00142, 0001822565-2020-00143.
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Event Description
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It was reported that the holes of proximal side of the greater trochanter femoral nail had holes for left side.No patient involvement.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h4, h6, h10.The complaint sample was evaluated and the reported event was confirmed.The visual inspection noted that the holes machined are in an incorrect orientation in relation to the nail.Device history record was reviewed and no discrepancies were found.The root cause is determined to be a manufacturing deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.
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Search Alerts/Recalls
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